(19)
(11) EP 4 342 536 A3

(12) EUROPEAN PATENT APPLICATION

(88) Date of publication A3:
26.06.2024 Bulletin 2024/26

(43) Date of publication A2:
27.03.2024 Bulletin 2024/13

(21) Application number: 23214280.2

(22) Date of filing: 29.04.2013
(51) International Patent Classification (IPC): 
A61K 9/14(2006.01)
A61K 31/48(2006.01)
A61P 3/08(2006.01)
A61P 3/10(2006.01)
A61K 9/20(2006.01)
A61K 31/4985(2006.01)
A61P 25/16(2006.01)
(52) Cooperative Patent Classification (CPC):
A61K 31/48; A61K 9/2018; A61K 9/14; A61K 9/2077; A61K 31/4985; A61P 25/16; A61P 3/08; A61P 3/10
(84) Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(30) Priority: 30.04.2012 US 201213460452

(62) Application number of the earlier application in accordance with Art. 76 EPC:
21203207.2 / 3960160
19191600.6 / 3620155
13721874.9 / 2844229

(71) Applicant: VeroScience LLC
Tiverton RI 02878 (US)

(72) Inventors:
  • CINOTTA, Anthony
    Tiverton, 02878 (US)
  • BOWE, Craig Michael
    Encinitas, 92024 (US)
  • STEARNS, Paul Clark
    San Diego, 92126 (US)
  • WESTON, Laura Jean
    Escondido, 92026 (US)

(74) Representative: Fisher, Abbie 
Withers & Rogers LLP 2 London Bridge
London SE1 9RA
London SE1 9RA (GB)

   


(54) BROMOCRIPTINE FORMULATIONS


(57) A dosage form comprising: bromocriptine mesylate and one or more excipients; wherein the dosage form provides for absorption of a substantial amount of bromocriptine through the gastric and/or intestinal mucosa when administered to a subject; wherein the bromocriptine has a Dv90 of about 15 µm or lower; wherein the bromocriptine has a particle size distribution with a span of about 2 or lower; and wherein the dosage form exhibits a pharmacokinetic profile wherein the time to maximum plasma concentration (Tmax) of bromocriptine is between about 30 and about 60 minutes following oral administration of the dosage form to the subject under fasting conditions or the Tmax of bromocriptine is between about 90 and about 120 minutes following oral administration of the dosage form to the subject under high fat fed conditions; wherein the dosage form is in the form of a solid dosage form.





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